Reports from spontaneous reporting systems (SRS) are hypothesis generating. Additional evidence such as more reports is required to determine whether the generated drug-event associations are in fact safety signals. However, underreporting of adverse drug reactions (ADRs) delays signal detection. Through the use of natural language processing, different sources of real-world data can be used to proactively collect additional evidence for potential safety signals. This study aims to explore the feasibility of using Electronic Health Records (EHRs) to identify additional cases based on initial indications from spontaneous ADR reports, with the goal of strengthening the evidence base for potential safety signals. For two confirmed and two potential signals generated by the SRS of the Netherlands Pharmacovigilance Centre Lareb, targeted searches in the EHR of the Leiden University Medical Centre were performed using a text-mining based tool, CTcue. The search for additional cases was done by constructing and running queries in the structured and free-text fields of the EHRs. We identified at least five additional cases for the confirmed signals and one additional case for each potential safety signal. The majority of the identified cases for the confirmed signals were documented in the EHRs before signal detection by the Dutch Medicines Evaluation Board. The identified cases for the potential signals were reported to Lareb as further evidence for signal detection. Our findings highlight the feasibility of performing targeted searches in the EHR based on an underlying hypothesis to provide further evidence for signal generation.

来自自发报告系统（SRS）的报告是假设生成。需要更多的证据（例如更多的报告）来确定生成的药物事件关联是否实际上是安全信号。然而，药物不良反应 (ADR) 的漏报会延迟信号检测。通过使用自然语言处理，可以使用不同来源的现实世界数据来主动收集潜在安全信号的额外证据。本研究旨在探讨使用电子健康记录 (EHR) 根据自发 ADR 报告的初步迹象来识别其他病例的可行性，目的是加强潜在安全信号的证据基础。对于荷兰药物警戒中心 Lareb 的 SRS 生成的两个已确认信号和两个潜在信号，使用基于文本挖掘的工具 CTcue 在莱顿大学医学中心的 EHR 中进行了有针对性的搜索。对其他病例的搜索是通过在电子病历的结构化和自由文本字段中构建和运行查询来完成的。我们针对已确认信号确定了至少 5 个额外案例，针对每个潜在安全信号又确定了 1 个额外案例。在荷兰药品评估委员会检测到信号之前，大多数已确认信号的已识别病例已记录在电子病历中。已识别出的潜在信号案例已报告给 Lareb，作为信号检测的进一步证据。我们的研究结果强调了基于基本假设在电子病历中进行有针对性的搜索的可行性，以为信号生成提供进一步的证据。